Cleared Traditional

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

K003627 · Exelint International, Co. · General Hospital
Feb 2001
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K003627 is an FDA 510(k) clearance for the EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on February 8, 2001, 76 days after receiving the submission on November 24, 2000. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K003627 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2000
Decision Date February 08, 2001
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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